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NAERINGSPH-Nærings-phd

The Efficacy and Safety of Enzymatic liberated Fish Oil (ELFO) as supplement nutrition in the adult with asthma and COPD

Alternative title: Effekten og sikkerheten til enzymatisk frigjort fiskeolje (ELFO) som supplementernæring hos voksne med astma og KOLS

Awarded: NOK 1.8 mill.

Project Number:

332941

Application Type:

Project Period:

2022 - 2024

Funding received from:

Research has shown that marine foods carry nutritional potential that promotes human health, particularly intake of high-quality fatty acid. CARDIO® is an unrefined salmon oil-based soft-gel from salmon rest raw material containing 21 different fatty acids, lipopeptides, antioxidants, and other micro metabolites. Asthma and chronic obstructive pulmonary disease (COPD) are both serious and globally distributed diseases and have several similarities such as airway obstructions, mucus production, long-term medication, and decreased quality of life. Both trials will aim to provide data on the possible difference between patients receiving CARDIO® or placebo (neutral oil) on anti-inflammatory outcomes and safety. We propose that adding CARDIO® as a supplement to best standard care (BSC) will have a positive effect on the inflammatory process leading to improved asthma control. Primary endpoints; the shown difference in frequency of asthma exacerbation in the study population. The pathogenesis of COPD is complex. There is no evidence from clinical trials, that the existing medications for COPD modify the long-term decline in lung function. The primary endpoint will be to study if ox-LDL has affected the pathogenesis in COPD patients. Secondary outcomes in both studies will be to explore changes in lung function tests, frequency of used emergency medicine, biomarkers, changes in quality of life, and rate of exacerbations. We believe these clinical trials will contribute to the scientific field of marine products used in healthcare. The Ph.D. project is an interaction between groundbreaking work in pulmonary medicine, gastroenterology, and patient-centered clinical research, with links to advanced analytical methods and collaboration with highly qualified research groups national and international.

This Ph.D.- project aims to document Enzymatic liberated Fish Oil (ELFO) anti-inflammatory effect on asthma and COPD patients. The anti-inflammatory effect has been proven through earlier research in laboratories and there is a good reason to believe that this will have a similar effect on humans. The current treatment of Asthma and COPD is mainly expensive drugs with unwanted side- effects. Two clinical trials will be conducted at Clinical Trial Unit at Hofseth BioCare in the city of Ålesund, in collaboration with Møre and Romsdal Health trust and NTNU. The clinical studies with ELFO supplements will be done as a randomized placebo-controlled and double-blinded single-center study. The participants will be randomized in one of two treatment trials and undergo a prescreening before inclusion, and follow-ups for 24 weeks. Expected results are reduced need for traditional drug use, fewer exacerbations, and better quality of life. These results will be the first step to a pharmaceutical approach for ELFO in the treatment of asthma and COPD. A pharmaceutical approach will provide cheaper medicines without side- effects at the same time as Hofseth BioCare expands the market for the sale of ELFO. The purpose of this Ph.D.-project is to detect possible new indications for the use of Cardio for specific lung health challenges. one of the challenges in this project is to recruit enough participants for the studies and prevent dropouts. Information about the project will be presented through local media channels and social media networks. Public lung outpatient clinics, as well as doctors' offices in the region, will be involved in the recruitment of participants. To prevent dropouts, information and good follow-up are crucial. The Ph.D.-project lasts three years and is a collaboration between Hofseth BioCare (HBC), HMR, and NTNU. Three articles are planned in this Ph.D. course.

Funding scheme:

NAERINGSPH-Nærings-phd